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Tag: FDA Regulations

16
Sep, 2016
Medical Device Applications

FDA Finds Cancer Drugs Websites Misleading

  • By
  • Andrew Steinberg
  • |
  • FDA News & Recalls
  • |
  • 0 Comments

Because cancer is one of the leading causes of death in adults, the market for cancer drugs has welcomed new treatments with open arms; but are new treatments all...

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16
Sep, 2016
3d printed medical devices

FDA Commissioner Advises Against Use of Real World Data

  • By
  • Andrew Steinberg
  • |
  • Drug & Device Manufacturers,FDA News & Recalls
  • |
  • 0 Comments

Pharmaceutical and medical device companies have been complaining for years that the FDA approval process is long and expensive, stifling medical innovation. In response, legislators have included new language...

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15
Sep, 2016
chantix

FDA To Doctors: Money Is Clouding Judgment

  • By
  • Andrew Steinberg
  • |
  • Dangerous Prescription Drug,FDA News & Recalls
  • |
  • 0 Comments

The FDA’s recent findings over the popular drug Chantix have some painfully obvious advice for doctors: accepting money and gifts from pharmaceutical companies could cloud judgment when prescribing medication....

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13
Sep, 2016
Medical Device Approvals

FDA Updates Draft Guidance To Outsource Medical Device Approvals

  • By
  • Andrew Steinberg
  • |
  • FDA News & Recalls
  • |
  • 0 Comments

The U.S. Food and Drug Administration (FDA) released a draft guidance addressing the program that approves third parties to review premarket notification (510(k)) submissions for medical devices. The guidance...

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09
Sep, 2016
FDA

Is The FDA Getting Too Lax?

  • By
  • Andrew Steinberg
  • |
  • FDA News & Recalls
  • |
  • 0 Comments

The U.S. Food and Drug Administration is supposed to be the watchdog agency overseeing medical device and drug companies and ensuring they are following regulations, but it appears the...

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07
Sep, 2016
off-label

FDA Will Hold Public Hearing On Off-Label Communications

  • By
  • Andrew Steinberg
  • |
  • FDA News & Recalls
  • |
  • 0 Comments

The U.S. Food and Drug Administration (FDA) announced it will hold a public meeting with the healthcare industry, including pharmaceutical and medical device companies, doctors, patients, research institutions, healthcare...

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26
Aug, 2016
EpiPen

Is The EpiPen’s High Price The FDA’s Fault?

  • By
  • Andrew Steinberg
  • |
  • Drug & Device Manufacturers,FDA News & Recalls
  • |
  • 0 Comments

For people with severe allergies, epinephrine injectors like the EpiPen are a lifeline in dire situations. Living without an EpiPen nearby is risky, but paying for the little injectors...

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25
Aug, 2016
FDA

Medical Device Manufacturers Agree To Pay FDA $1 Billion

  • By
  • Andrew Steinberg
  • |
  • Drug & Device Manufacturers,FDA News & Recalls
  • |
  • 0 Comments

The U.S. Food and Drug Administration (FDA) takes a lot of criticism, but in its defense, the agency lacks the funding and manpower to address many expressed concerns. But...

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24
Aug, 2016
3d printed medical devices

FDA Says Citizens Petitions Are Slowing Agency Down

  • By
  • Andrew Steinberg
  • |
  • Drug & Device Manufacturers,FDA News & Recalls
  • |
  • 0 Comments

It’s not easy being the U.S. Food and Drug Administration (FDA). The agency must straddle a fine line between approving lifesaving medical treatments and protecting consumers from harmful products....

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23
Aug, 2016
3d printed medical devices

3D Printing Industry Speaks Its Mind Over Proposed FDA Regulations

  • By
  • Andrew Steinberg
  • |
  • Drug & Device Manufacturers,FDA News & Recalls
  • |
  • 0 Comments

3D Printed medical devices are a new frontier in healthcare, and the FDA is struggling to understand the best way to regulate them. This past May, the agency released...

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